Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.
The new requirement would cover dozens of medications: antipsychotics, stimulants, antidepressants, narcotics and ...
"If only the doctor had warned me of this terrible complication, I never would have agreed to his treatment." When a patient has a poor outcome, that statement is typically the basis for a malpractice ...